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510(k) Data Aggregation
(103 days)
KIMTECH Polaris Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid
The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.
The provided text describes the acceptance criteria and study results for "KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid." This is a medical device, specifically examination gloves, and the acceptance criteria and studies are related to its physical properties, biocompatibility, and resistance to permeation by certain chemicals.
Here's an analysis based on your request:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard Where Limits Test Limits Set) | Reported Device Performance (Results) |
|---|---|
| Dimensions (ASTM D 6319) | Meets Requirements |
| Length: 220 mm minimum (XS, S), 230 mm minimum (M, L, XL) | All sizes comply with length dimensions |
| Width (mean): 70 mm minimum (XS), 80 mm minimum (S), 95 mm minimum (M), 110 mm minimum (L), 120 mm minimum (XL) | All sizes comply with width dimensions |
| Finger Thickness: 0.05 mm minimum | All sizes comply with Finger Thickness dimensions |
| Palm Thickness: 0.05 mm minimum | All sizes comply with Palm Thickness dimensions |
| Physical Properties (ASTM D 6319) | Meets Requirements |
| Before Aging: Tensile Strength: ≥ 14 MPa, Ultimate elongation: ≥ 500% | Complies both before and after accelerated aging |
| After Aging: Tensile Strength: ≥ 14 MPa, Ultimate elongation: 400% | Complies both before and after accelerated aging |
| Freedom from Pinholes (ASTM D 5151) | Meets Requirements |
| AQL 2.5, No leakage | Pass (AQL 0.65) - Note: Subject device has a tighter AQL than the predicate |
| Powder-Free (ASTM D 6124) | Meets Requirements |
| ≤ 2 mg / glove | Passed at 240 min) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the exact sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, or how many individual permeation tests were conducted for each chemical). However, it references recognized standards like ASTM D6319 (for dimensions and physical properties, which dictates sampling plans), ASTM D5151 (for holes, which specifies AQLs), and ISO 2859-1:1999 (Sampling Procedures and Tables for Inspection by Attributes). Meeting these AQLs (Acceptable Quality Levels) implies specific sample sizes would have been drawn and tested in accordance with the standards.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, given it's an FDA 510(k) submission, the studies would have been conducted by the manufacturer (Kimberly-Clark Corporation) or their designated testing facilities, likely in a controlled, prospective manner to generate data for the submission. The testing standards are international (ASTM, ISO), suggesting globally recognized methods.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. The testing described involves objective, quantitative measurements of physical and chemical resistance properties according to established engineering and material science standards (ASTM, ISO). "Ground truth" in this context is defined by the objective measurement procedures and acceptance criteria outlined in these standards, not by expert consensus or interpretation of images/clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods like 2+1 or 3+1 refer to processes for resolving disagreements among multiple human readers in diagnostic imaging or clinical studies. The studies presented here are laboratory-based, objective material property tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. This submission is for a physical medical device (examination gloves), not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. As stated above, this is not an AI algorithm. The performance described is inherent to the physical glove material and construction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by objective, quantitative measurements conducted in a laboratory setting according to internationally recognized standards and test methods. For example:
- Dimensions: Measured directly using calibrated instruments.
- Tensile Strength & Elongation: Measured using universal testing machines as per ASTM standards.
- Freedom from Pinholes: Determined by water leak tests following ASTM D5151.
- Powder Content: Measured gravimetrically as per ASTM D6124.
- Biocompatibility: Determined by laboratory animal studies (e.g., skin irritation, sensitization, systemic toxicity) following ISO 10993 guidelines, which define the biological response.
- Permeation Resistance: Measured by quantifying breakthrough time of specific chemicals using analytical techniques (e.g., chromatography) as per ASTM D6978-05.
8. The sample size for the training set:
This is not applicable. These studies are for a physical product validation, not for training an AI or machine learning model. There is no "training set" in this context.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this type of device validation.
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(102 days)
KIMTECH Polaris Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl
The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are 245mm in length and dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.
The provided document describes the safety and performance testing of KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves. However, this is a 510(k) premarket notification for a medical glove, not an AI/ML medical device. Therefore, the information required to answer the specific questions about acceptance criteria for an AI/ML device, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, or clinical study design (MRMC), is not present in this document.
The document focuses on non-clinical performance tests of the physical and chemical properties of the gloves.
Here's an attempt to extract relevant "acceptance criteria" and "reported performance" based on the provided document, framed as close as possible to the request, while highlighting the limitations for an AI/ML context.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is for a physical medical device (gloves), the "acceptance criteria" are defined by recognized standards (e.g., ASTM, ISO) for physical properties, chemical resistance, and biocompatibility.
| Test Category | Acceptance Criteria (from Standards) | Reported Device Performance (KIMTECH™ Polaris™ Nitrile Gloves) |
|---|---|---|
| Dimensions | Length: ≥ 230 mm | |
| Width (mean): ≥ 70 mm | ||
| Finger/Palm Thickness: ≥ 0.05 mm | Meets requirements (All sizes comply with length, width, and thickness dimensions) | |
| Physical Properties | Before Aging: | |
| Tensile Strength: ≥ 14 MPa | ||
| Ultimate Elongation: ≥ 500% | ||
| After Aging: | ||
| Tensile Strength: ≥ 14 MPa | ||
| Ultimate Elongation: ≥ 400% | Meets requirements (Complies both before and after accelerated aging) | |
| Freedom from Pinholes | ASTM D6319 G1, AQL 2.5 (7 Accept, 8 Reject) | |
| No leakage | Pass (AQL 0.65) - Note: Subject glove AQL is tighter than the standard, indicating better performance. | |
| Powder-Free | ≤ 2 mg / glove | Passed at |
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(98 days)
Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate
, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested
The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The device is a disposable examination glove. The subject gloves are made of Synthetic: Nitrile & Polychloroprene. They are non-sterile and intended for Over-The-Counter use.
The provided document is a 510(k) Premarket Notification for medical examination gloves. It details the safety and performance characteristics of "KIMTECH™ PRIZM™ Multi-Layered Exam Glove" and "KIMTECH™ PRIZM™ Xtra Multi-Layered Exam Glove," particularly regarding their resistance to chemotherapy drugs, opioid Fentanyl Citrate, and simulated gastric acid.
Here's an analysis of the acceptance criteria and the study proving the device meets these criteria, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally established standards from ASTM and ISO. The reported device performance is indicated as "Pass" for all tested attributes. Chemical permeation times are specific performance metrics for the glove's resistance to various substances.
Table of Acceptance Criteria and Reported Device Performance
| Attribute / Test Standard | Acceptance Criteria (Standard / Threshold) | Reported Device Performance (KIMTECH™ PRIZM™ / KIMTECH™ PRIZM™ Xtra) |
|---|---|---|
| General Glove Properties | ||
| Common Name | Synthetic Examination Glove | Same (Synthetic Examination Glove) |
| Intended Use | Disposable device for medical purposes to prevent contamination between patient and examiner. | Same |
| Base Material | Synthetic: Nitrile | Similar: Synthetic (Nitrile & Polychloroprene). Considered acceptable as it does not adversely impact safety or performance. |
| Color | NA (Different from predicate, but deemed not to adversely impact safety or performance) | Dark Violet outer surface, Deep Magenta inside surface (Subject gloves) |
| Product Code | LZA, LZC, QDO | Same (LZA, LZC, QDO) |
| Sterile vs. Non-sterile | Non-sterile | Non-sterile |
| Prescription or OTC | OTC | OTC |
| Single Use-Disposable | Yes | Yes |
| Physical Dimensions | ||
| Overall Length (ASTM D6319) | Minimum: 230mm | All sizes comply with length dimensions |
| Overall Width (ASTM D6319) | Minimum: 110 + 10mm | All sizes comply with length dimensions |
| Palm & Finger Thickness (ASTM D6319) | Minimum: Palm: 0.05mm, Finger: 0.05mm | All sizes comply with length dimensions |
| Mechanical Properties | ||
| Tensile Strength: Before & After Aging (ASTM D6319) | Minimum: 14MPa | Complies both before and after accelerated aging |
| Ultimate Elongation: Before & After Aging (ASTM D6319) | Minimum: Before: 500%, After: 400% | Complies both before and after accelerated aging |
| Barrier Integrity | ||
| Freedom from holes (ASTM D6319) | G1, AQL 2.5 (7 Accept, 8 Reject) | Pass |
| Powder Free (ASTM D6319) | Maximum 240 min is performance criterion. | >240 min |
| Capecitabine (26 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Carmustine (3.3 mg/ml) | Not explicitly stated, but 47.5 min is reported. Caution statement issued. | 47.5 min (Caution: below 60 min) |
| Cisplatin (1 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Cyclophosphamide (20 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Dacarbazine (10 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Doxorubicin HCL (2 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Eribulin Mesylate (0.5 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Etoposide (20 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Floxuridine (100 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Fluorouracil (50 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Ifosfamide (50 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Lenvatinib (20 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Mitoxantrone (2 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Paclitaxel (6 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Pemetrexed (25 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Sorafenib Tosylate (200 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Tamoxifen (2 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Thiotepa (10 mg/ml) | Not explicitly stated, but 38.2 min is reported. Caution statement issued. | 38.2 min (Caution: below 60 min) |
| Vinblastine Sulfate (1 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Vincristine Sulfate (1 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Vinorelbine (10 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Fentanyl Citrate (100mcg/2mL) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Simulated Gastric Acid (0.2% NaCl in 0.7% HCL) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Fentanyl in Gastric Acid (50/50 mix) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| KIMTECH™ PRIZM™ Xtra Multi-Layered Exam Glove | ||
| Cabazitaxel (60 mg/1.5ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Capecitabine (26 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Carmustine (3.3 mg/ml) | Not explicitly stated, but 37.3 min is reported. Caution statement issued. | 37.3 min (Caution: below 60 min) |
| Cisplatin (1 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Cyclophosphamide (20 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Dacarbazine (10 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Doxorubicin HCL (2 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Eribulin Mesylate (0.5 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Etoposide (20 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Floxuridine (100 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Fluorouracil (50 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Ifosfamide (50 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Lenvatinib (20 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Mitoxantrone (2 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Paclitaxel (6 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Pemetrexed (25 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Sorafenib Tosylate (200 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Tamoxifen (2 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Thiotepa (10 mg/ml) | Not explicitly stated, but 30.1 min is reported. Caution statement issued. | 30.1 min (Caution: below 60 min) |
| Vinblastine Sulfate (1 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Vincristine Sulfate (1 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Vinorelbine (10 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Fentanyl Citrate (100mcg/2mL) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Simulated Gastric Acid (0.2% NaCl in 0.7% HCL) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Fentanyl in Gastric Acid (50/50 mix) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Biocompatibility | ||
| Systemic Toxicity Test (ISO 10993-11) | Extracts should not elicit a systemic response in the model animal. | Under study conditions, device extracts did not elicit a systemic response in the model animal. |
| Primary Skin Irritation on Rabbits (ISO 10993-10) | Extracts should not be an irritant to the animal model. | Under study conditions, polar and non-polar device extracts were found not to be an irritant to the animal model. |
| Magnusson & Kligman Guinea pig Maximization (ISO 10993-10) | Extracts should not be sensitizers to the animal model. | Under study conditions, polar and non-polar device extracts were found not to be sensitizers to the animal model. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size (number of gloves or test replicates) used for each specific test. It indicates that "Non-Clinical Testing was conducted to demonstrate that the two proposed devices met all required design specifications." The testing appears to follow relevant ASTM and ISO standards, which would typically specify sample sizes.
The data provenance is from non-clinical testing conducted by Kimberly Clark Corporation, based in the United States. The testing is performed for premarket notification, indicating it's prospective data for the purpose of demonstrating substantial equivalence to a legally marketed predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a medical examination glove, and the performance evaluation is based on objective, quantifiable physical and chemical tests (e.g., tensile strength, resistance to chemical permeation, and biocompatibility) against established standards. There is no qualitative assessment or "ground truth" to be established by human experts in the context of diagnostic interpretation.
4. Adjudication method for the test set
This information is not applicable. As stated above, the evaluation relies on objective measurements against engineering and chemical standards, not on human interpretation that would require adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This is a 510(k) submission for exam gloves, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable, as this is not an AI-powered device.
7. The type of ground truth used
The "ground truth" for evaluating these examination gloves is provided by established international and national standards for medical device performance. Specifically:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D412-2006a: Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- ASTM D573-2004: Standard Test Method for Rubber-Deterioration in an Air Oven
- ASTM D3767-03: Standard Practice for Rubber Measurement of Dimensions
- ASTM D5151-2006: Standard Test Method for Detection of holes in Medical Gloves
- ASTM D6124-2006: Standard Tested Method for Residual Powder on Medical Gloves
- ASTM D6978-05 (Reapproved 2013): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
- ISO 2859: Sampling Procedures and Tables for Inspection by Attributes
- ISO 10993-10: Biological Evaluation of medical Devices-Part 10: Tests for Irritation and Sensitization
- ISO 10993-11: Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
These standards define the methodologies and acceptable limits for various physical, chemical, and biological properties of the gloves.
8. The sample size for the training set
This information is not applicable. The device is a physical product (exam glove), not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device.
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(87 days)
KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid
The Nitrile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
KIMTECH™ Purple Nitrile™ Examination Gloves, Powder Free, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric acid and Fentanyl in Simulated Gastric acid are single use only, non-sterile, disposable gloves. The powder-free gloves are made of a synthetic copolymer of acrylonitrile and butadiene with a purple color additive. The gloves are available in extra small, medium, large, and extra-large sizes.
This document is a 510(k) Premarket Notification for KIMTECH™ Purple Nitrile™ Powder Free Examination Gloves. It focuses on demonstrating that the proposed device is substantially equivalent to legally marketed predicate devices, particularly concerning its resistance to permeation by chemotherapy drugs, fentanyl citrate, simulated gastric acid, and fentanyl in simulated gastric acid.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the permeation resistance of the gloves are defined by the "Minimum Breakthrough Detection Time" for each substance. For other characteristics, the acceptance criteria are generally "Complies with" or "Pass" based on recognized ASTM and ISO standards.
| Attribute/Test | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Chemotherapy Drugs (Permeation Time) | ASTM D6978-05 (Re-approved 2013): Minimum Breakthrough Detection Time (implied requirement is to demonstrate significant barrier, often >240 min for most drugs but with specific exceptions) | Reported Breakthrough Detection Time (minutes) |
| Blenoxane | >240 | >240 |
| Busulfan | >240 | >240 |
| Carmustine (BiCNU) | (Note: Extremely low permeation time reported) | >3.6 (Warning: Do Not Use With) |
| Cisplatin | >240 | >240 |
| Cyclophosphamide/cytoxan | >240 | >240 |
| Cytarabine | >240 | >240 |
| Dacarbazine (DTIC) | >240 | >240 |
| Daunorubicin | >240 | >240 |
| Docetaxel | >240 | >240 |
| Doxorubicin | >240 | >240 |
| Ellence | >240 | >240 |
| Etoposide/Toposar | >240 | >240 |
| Fludarabine | >240 | >240 |
| Fluorouracil | >240 | >240 |
| Gemcitabine | >240 | >240 |
| Idarubicin | >240 | >240 |
| Ifosfamide | >240 | >240 |
| Irinotecan | >240 | >240 |
| Mechlorethamine HCL | >240 | >240 |
| Melphalan | >240 | >240 |
| Methotrexate | >240 | >240 |
| Mitomycin C | >240 | >240 |
| Mitoxantrone | >240 | >240 |
| Paclitaxel | >240 | >240 |
| Paraplatin | >240 | >240 |
| Rituximab | >240 | >240 |
| Thiotepa | (Note: Extremely low permeation time reported) | >15.9 (Warning: Do Not Use With) |
| Trisenox | >240 | >240 |
| Vincristine Sulfate | >240 | >240 |
| Opioid Fentanyl Citrate (Permeation Time) | ||
| Fentanyl Citrate | >240 | >240 |
| Simulated Gastric Acid (Permeation Time) | ||
| Gastric Acid (simulated) | >240 | >240 |
| Fentanyl in Simulated Gastric Acid (Permeation Time) | ||
| Fentanyl in Gastric Acid | >240 | >240 |
| Dimensions: Overall Length | ASTM D6319 Minimum: 230mm | All sizes comply with length dimensions |
| Dimensions: Width (mean) | ASTM D6319 Minimum: 70 + 10mm (implied range based on standard) | All sizes comply with length dimensions |
| Dimensions: Palm & Finger Thickness | ASTM D6319 Min. Palm: 0.05mm, Finger: 0.05mm | All sizes comply with length dimensions |
| Tensile Strength: Before Aging | ASTM D6319 Min: 14MPa | Complies both before and after accelerated aging |
| Tensile Strength: After Aging | ASTM D6319 Min: 14MPa | Complies both before and after accelerated aging |
| Ultimate Elongation: Before Aging | ASTM D6319 Minimum: 500% | Complies both before and after accelerated aging |
| Ultimate Elongation: After Aging | ASTM D6319 Minimum: 400% | Complies both before and after accelerated aging |
| Freedom from Holes | ASTM D6319 G1, AQL 2.5 (7 Accept, 8 Reject) | Pass |
| Powder-Free | ASTM D6319 Maximum |
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(162 days)
KIMGUARD ONE-STEP Sterilization Wrap
KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:
· Pre-vacuum steam at 270°F / 132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for models KC100 and KC200.
· 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 43.3 °C for models KC100 and KC200.
KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.
Test results validated that KIMGUARD* ONE-STEP* Sterilization Wraps (KC100, KC200) allowed sterilization of the enclosed devices by the ethylene oxide sterilization and by pre-vacuum cycles.
These models of the KIMGUARD* ONE-STED* Sterilization Wrap have been validated for use with the ethylene oxide and pre-vacuum cycles in Table 1 (see page 2 of 2)
KIMGUARD* ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two edges. This allows for convenient wrapping with two sheets simultaneously.
The sheets of sterilization wrap are square or rectanqular fabric produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The wrap fabric (white or blue color) is composed of polypropylene with the addition of less than 2% by weight of phthalocvanine blue pigment (blue fabric only), less than 1% by weight titanium dioxide pigment, and less than 0.009% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.
This FDA 510(k) summary describes KIMGUARD® ONE-STEP® Sterilization Wrap intended to enclose medical devices for sterilization and maintain sterility.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Measured Performance) | Reported Device Performance (Results) |
|---|---|
| Maintain Sterility (for Pre-vacuum steam sterilization at 270°F / 132°C for 4 minutes with 20 minutes dry time) | Passed |
| Maintain Sterility (for 100% ethylene oxide (EO) at 725-735 mg/L, 131°F / 55°C, 40-80% RH for 60 minutes with 8 hours aeration at 43.3°C or 12 hours at 55°C) | Passed |
| Maintenance of 365-Day Package Integrity (sterility maintenance) | Passed |
| Ethylene Oxide Sterilant Penetration | Passed |
| Pre-Vacuum Steam Sterilant Penetration | Passed |
| Post Sterilization Biocompatibility Testing (Cytotoxicity, ISO 10993-5: 2009; Irritation, ISO 10993-10:2010; Sensitization, ISO 10993-10: 2010) | Passed |
| Maximum Wrapped Package Content Weights for KC100 (Very Light Weight Package) | Up to 3 lbs. (Tested with 16 huck towels (17"x 29")) |
| Maximum Wrapped Package Content Weights for KC200 (Light Weight Package) | Up to 6 lbs. (Tested with 2 huck towels (17"x 29"), 2 fluid resistant U-drapes (68"x 109"), 1 fluid resistant universal bar drape (70" x 108")) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for the "Maintenance of 365-Day Package Integrity," "Sterilant Penetration," and "Biocompatibility" tests. For the KIMGUARD® ONE-STEP® Sterilization Wrap Recommendations for Use (Table 1), the "test set" can be considered the specific configurations of loads used to validate the maximum wrapped package content weights:
- KC100: 16 huck towels (17"x 29") weighing 3 lbs.
- KC200: 2 huck towels (17"x 29"), 2 fluid resistant U-drapes (68"x 109"), 1 fluid resistant universal bar drape (70" x 108") weighing 6 lbs.
The data provenance is not explicitly mentioned as country of origin, but the applicant is Halyard Health, located in Alpharetta, GA, USA. The studies appear to be prospective as they were conducted to validate the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a sterilization wrap, not an AI/imaging device. Therefore, the concept of "experts" to establish ground truth in the context of diagnostic interpretation is not applicable here. The validation involves standardized performance tests for sterilization and material properties. Compliance with relevant standards (e.g., ISO 10993 for biocompatibility) would be performed by qualified personnel in testing laboratories.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and study. Adjudication methods are typically used in clinical studies involving interpretation by multiple readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI software. The device itself (the sterilization wrap) has a standalone performance (its ability to maintain sterility and allow sterilant penetration). The nonclinical tests essentially evaluate this "standalone" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by:
- Quantitative measurements and observations based on standardized test methods for:
- Sterilant penetration (ensuring the sterilant reaches the enclosed medical device).
- Microbiological challenge (implied by "maintenance of sterility" tests, indicating no microbial ingress).
- Physical integrity tests to confirm the wrap remains intact over time, preventing contamination.
- Biocompatibility tests according to ISO standards, which involve specific physiological responses.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable as there is no training set for this device.
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(164 days)
KIMGUARD ONE-STEP Sterilization Wrap
KIMGUARD ONE-STEP® Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:
- V-PRO® 60 Low Temperature Sterilization System that include:
- o Lumen Cycle
- Non Lumen Cycle o
- Flexible Cycle O
KIMGUARD* ONE-STEP® Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.
KIMGUARD* ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.
The blue or white sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) process. The blue wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of anti-static treatment. The white sheet has the same material composition but contains no blue pigment. The wrap allows a sterilized package to be opened aseptically.
I am sorry, but based on the provided document, the information required to compose the detailed response for "acceptance criteria and the study that proves the device meets the acceptance criteria" as requested is not available. The document is a 510(k) summary for a sterilization wrap, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics in the format requested for a device that typically involves AI or human interpretation.
Specifically, the document states:
- "All results of testing met acceptance criteria demonstrating that the KIMGUARD* ONE-STEP® Sterilization Wrap allows sterilization of contents by the V-PRO® 60 Low Temperature Sterilization System (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) and maintains sterility of contents until used."
- It lists a "Summary of Testing Performed" table with "Results" as "Passed" for "Sterilant Penetration", "Maintenance of Package Integrity (30 Days)", "Performance Testing", and "Material Biocompatibility."
However, it does not provide:
- A table of specific acceptance criteria and reported device performance (e.g., quantifiable metrics like sensitivity, specificity, accuracy, or other performance thresholds with numerical results). The results are simply stated as "Passed."
- Sample sizes used for the test set and data provenance.
- Number of experts and their qualifications used to establish ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study details.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document describes a medical device (sterilization wrap) which functions as a physical barrier and facilitator of sterilization, not an AI-powered diagnostic or interpretive device. Therefore, the types of studies and performance metrics typically associated with AI/software-as-a-medical-device (SaMD) are not applicable here.
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(176 days)
KIMGUARD ONE STEP STERILIZATION WRAP
KIMGUARD* ONE-STEP* Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:
- . Sterilucent PSD-85 Hydrogen Peroxide Sterilizer that include:
- Lumen Cycle and o
- Non-Lumen Cycle. o
KIMGUARD* ONE-STEP* Sterlization Wrap (KC100, KC200, KC300 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.
Test results validated that KIMGUARD ONE-STEP® Sterilization Wraps (KC100, KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (i.e., both the Lumen and Non-Lumen Cycles). Additionally, the KIMGUARD ONE-STEP® Sterilization Wrap was validated to allow effective aeration under the pre-programmed PSD-85 Sterilization Cycles.
The PSD-85 Lumen Cycle has been validated to sterilize a load of up to ten (10) pounds (combined pouch and wrapped tray load) containing a maximum of ten (10) single channel stainless steel lumens per load with the following dimensions:
- · An inside diameter of 1 mm or larger and a length of 60 mm or shorter;
- An inside diameter of 2 mm or larger and a length of 250 mm or shorter;
· An inside diameter of 3 mm or larger and a length of 350 mm or shorter.
The PSD-85 Non-Lumen Cycle has been validated to sterilize a load of up to 25 pounds (combined pouch and wrapped tray load).
All models of the KIMGUARD ONE-STEP® Sterilization Wrap (KC100, KC300, KC400, KC500, and KC600) have been validated for use with the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer cycles in Table 1.
KIMGUARD* ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.
The sheets of sterilization wrap are square or rectangular fabric produced using a threelayer SMS (spunbound-meltblown-spunbound) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of antistatic treatment. The wrap allows a sterilized package to be opened aseptically.
This document is a 510(k) premarket notification for KIMGUARD* ONE-STEP* Sterilization Wrap. It asserts substantial equivalence to a previously cleared predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilant Penetration | Passed |
| Material Compatibility/Biocompatibility (post-sterilization) | Passed |
| Performance Testing (Post-Sterilization) | Passed |
| Maintenance of Package Integrity (180 Days) | Passed |
| Allows sterilization of enclosed medical devices by Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (Lumen and Non-Lumen Cycles) | Test results validated that KIMGUARD ONE-STEP® Sterilization Wraps allowed sterilization of the enclosed devices by the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer. |
| Allows effective aeration under pre-programmed PSD-85 Sterilization Cycles | KIMGUARD ONE-STEP® Sterilization Wrap was validated to allow effective aeration under the pre-programmed PSD-85 Sterilization Cycles. |
| Maintenance of sterility until used | KIMGUARD* ONE-STEP* Sterilization Wrap is intended to allow sterilization and also maintain sterility of the enclosed device(s) until used. Real-time testing following sterilization using Sterilucent PSD-85 Hydrogen Peroxide Sterilizer supports maintenance of package sterility for 180 days. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the testing of the sterilization wrap. It refers to "Test results validated" and "Real-time testing" but does not provide details on the number of units tested.
The data provenance is not specified in terms of country of origin. The studies are nonclinical tests conducted by the manufacturer (Halyard Health, formerly Kimberly-Clark Health Care).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is a sterilization wrap, not a diagnostic or AI-driven device requiring expert interpretation for ground truth. The "ground truth" for this type of device is established by objective performance criteria (e.g., microbial ingress, sterility testing, material compatibility) defined by regulatory standards and scientific methodologies, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient data by human readers. The tests performed for this sterilization wrap are objective, nonclinical performance tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. MRMC studies and AI assistance benefits are relevant to diagnostic devices or software that aid human interpretation. This document pertains to a physical sterilization wrap.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This refers to a medical device in the form of a physical sterilization wrap, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance of the sterilization wrap is established through various objective nonclinical tests based on recognized standards and methodologies. These include:
- Microbiological testing: To assess sterilant penetration and maintenance of sterility (e.g., bacterial challenge tests, sterility assurance level (SAL)).
- Physical and material property testing: To evaluate material compatibility, integrity, and aeration properties.
- Real-time shelf-life studies: To confirm the duration for which sterility is maintained.
The document explicitly states that testing was done "in accordance with the applicable requirements recommended in Pre-Market Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)." This guidance outlines the scientific methods to establish the "ground truth" for such devices.
8. The sample size for the training set
This information is not applicable. This refers to a manufactured product (sterilization wrap) rather than a machine learning model, so there is no training set in the context of AI.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above; there is no training set for a machine learning model.
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(209 days)
KIMGUARD SMART-FOLD STERILIZATION WRAP
KIMGUARD* Smart Fold* Sterilization Wrap (KC450 and KC650) is intended to enclose another medical device that is to be sterilized by a healthcare provider using:
- Advanced Sterilization Products' STERRAD® Sterilization Systems that include:
- STERRAD® 100S o
- STERRAD® NX® [Standard Cycle, Advanced Cycle] O
- STERRAD® 100NX®). [Standard Cycle, Flex Cycle, EXPRESS cycle, DUO Cycle] C
KIMGUARD* Smart Fold* Sterilization Wraps (KC450 are intended to allow sterlization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.
KIMGUARD* Smart Fold* Sterilization Wrap is comprised of two pre-shaped sheets of KIMGUARD Sterilization Wrap (blue base sheet and white intermediate sheet), which include reinforcement strips, and adhesively seamed on three edges to allow convenient wrapping with two sheets (i.e., white and blue) simultaneously. The fabric is a nonwoven spunbondmeltblown-spunbond (SMS) composite sheet manufactured with polypropylene with less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of a potassium phosphate anti-static treatment. Two strips of blue SMS are adhesively bonded to the white SMS intermediate layer for added strength. These reinforcement strips also function as a "reference line" to indicate proper sterilization tray placement by the user. The Smart-Fold wrap also incorporates pull tabs comprised of blue SMS material for convenient aseptic opening of wrapped packages.
The provided document is a 510(k) premarket notification for the KIMGUARD* Smart-Fold* Sterilization Wrap (Models KC450 and KC650). It describes the device's indications for use, comparison to predicate devices, and a summary of nonclinical tests performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it lists "Performance Requirements" and indicates "Passed" for each. The acceptance criterion implicitly seems to be "meeting the performance requirements" or demonstrating that the wrap "maintains sterility until used, after completion of the sterilization processes provided by the STERRAD® Sterilization Systems." The specific quantitative thresholds for these "passed" results are not detailed in this summary.
| Acceptance Criteria (Performance Requirement) | Reported Device Performance |
|---|---|
| STERRAD Sterilant Penetration | Passed |
| Material Compatibility/Biocompatibility post-sterilization using maximum hydrogen peroxide concentration (Cytotoxicity, Dermal Irritation) | Passed |
| Material Usability post-sterilization | Passed |
| Maintenance of Package Integrity (180 Days) | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set used in the nonclinical tests. For example, it doesn't state how many wraps were tested for "STERRAD Sterilant Penetration" or "Maintenance of Package Integrity."
The data provenance is not explicitly stated. The tests were performed as part of a 510(k) submission to the FDA, suggesting they were conducted by the manufacturer (Kimberly-Clark Health Care, later Halyard Health) to demonstrate device performance. It is implied to be prospective testing specifically for this submission, rather than retrospective data analysis from external sources. No information about country of origin of the data beyond the manufacturer's location (Roswell, GA) is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of information is generally not applicable to a device like a sterilization wrap. The "ground truth" for a sterilization wrap is typically established through objective laboratory testing according to established standards (e.g., ISO, ASTM, or specific sterilization system validation protocols) rather than expert interpretation of images or clinical assessment. Therefore, there's no mention of experts establishing ground truth in this context.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective human assessment, such as in clinical trials or image interpretation studies where multiple readers agree on a diagnosis. This is not relevant for the performance testing of a sterilization wrap, which relies on objective measurements and tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are used to evaluate the performance of diagnostic devices often involving human readers interpreting images or data, with or without AI assistance. This device is a physical medical device (sterilization wrap) rather than a diagnostic tool, so such a study is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable to the device under review. The KIMGUARD* Smart-Fold* Sterilization Wrap is a physical product, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. Type of Ground Truth Used
The "ground truth" for the performance tests appears to be established through:
- Objective laboratory testing and controlled experiments: For STERRAD Sterilant Penetration, this would involve measuring the presence or absence of sterilant penetration.
- Adherence to relevant ISO standards for biocompatibility: For Material Compatibility/Biocompatibility, this refers to ISO 10993-5:2009 (Cytotoxicity) and ISO 10993-10:2010 (Dermal Irritation).
- Functional testing: For Material Usability post-sterilization, this would likely involve evaluating the physical properties and integrity of the wrap after sterilization.
- Time-based integrity testing: For Maintenance of Package Integrity (180 Days), this involves evaluating the barrier properties and physical integrity of the package over an extended period.
The ground truth is based on the outcomes of these standardized and objective tests, rather than expert consensus, pathology, or clinical outcomes data in the way these terms are typically used for diagnostic or therapeutic devices.
8. Sample Size for the Training Set
This information is not applicable. As stated previously, this device is a physical medical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical medical device like a sterilization wrap.
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(52 days)
KIMGUARD ONE-STEP STERILIZATION WRAP
KIMGUARD* ONE-STEP* Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:
Advanced Sterilization Products STERRAD® Sterilization Systems that include: STERRAD® 50, 100S, and 200 STERRAD® NX® [Standard Cvcle. Advanced Cvcle] STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle]
KIMGUARD* ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.
Test results validated that KIMGUARD* ONE-STEP* Sterilization Wraps (KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® Sterilization Systems (STERRAD® 50, 100S, 200, NX® [Standard Cycle and Advanced Cycle] and 100NX® [Standard Cycle, EXPRESS Cycle, DUO Cycle]).
The KIMGUARD* ONE-STEP* Sterilization Wrap (Models KC300, KC400, K500, KC600) have been validated for use with the STERRAD® 50, STERRAD® 100S, STERRAD® 200, STERRAD® NX® and STERRAD® 100NX® cycles in Table 1.
KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Products STERRAD® Sterilization Systems are provided in Table 2.
KIMGUARD® ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD® Sterilization Wrap ultrasonically seamed on two edges. This allows for convenient wrapping with two sheets simultaneously.
The sheets of sterilization wrap are square or rectangular fabric produced using a threelayer SMS (spunbond-meltblown-spunbond) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.
The acceptance criteria are that the KIMGUARD® ONE-STEP® Sterilization Wrap maintains sterility until used, after being sterilized by the referenced STERRAD® Sterilization Systems.
Here's the summary of the study:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintenance of 180-Day Package Integrity | Passed |
| Allow sterilization of enclosed devices | Passed with all specified STERRAD® systems and cycles |
| Maintain sterility of enclosed devices until used | Passed |
2. Sample Size and Data Provenance for Test Set:
The document does not explicitly state the specific sample sizes for each test in the test set. It mentions "Test results validated" and "Performance testing was conducted," implying a test set was used. The data provenance is not specified (e.g., country of origin). It's a nonclinical study, so it wouldn't be retrospective or prospective in the human study sense.
3. Number of Experts and Qualifications for Ground Truth of Test Set:
This information is not provided in the document. As this is a non-clinical device (sterilization wrap), it's unlikely that "experts" in the medical sense (like radiologists) were used to establish ground truth for performance tests like package integrity or sterilization efficacy. Ground truth would be based on validated scientific and engineering testing protocols.
4. Adjudication Method for the Test Set:
The document does not mention an adjudication method. For non-clinical performance tests, adjudication (e.g., 2+1, 3+1 for human readers) is typically not applicable. The results are usually objectively measured against predefined pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or evaluative devices where human interpretation is involved. This device is a sterilization wrap, and its effectiveness is determined by objective physical and biological tests.
6. Standalone Performance:
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done, as this is a physical product being tested for its intrinsic performance (package integrity, ability to allow sterilization). The study involved "Performance testing" and "nonclinical tests" as described.
7. Type of Ground Truth Used:
The ground truth used for these tests would be based on:
- Standardized microbiological testing (to confirm sterilization efficacy and sterility maintenance).
- Physical integrity testing methods (to assess package integrity).
- Chemical indicators or biological indicators (for sterilization effectiveness).
- The tests adhere to established standards and protocols for sterilization validation and sterile barrier system performance.
8. Sample Size for the Training Set:
The concept of a "training set" is not applicable here as this is a physical device being evaluated for its performance through testing, not an AI/algorithm being trained on data.
9. How the Ground Truth for the Training Set Was Established:
As mentioned in point 8, the concept of a "training set" is not applicable to this type of device and study.
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(94 days)
KIMGUARD ONE-STEP STERILIZATION WRAP
KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to enclose another medical device that is to be sterilized by a healthcare provider using:
- Gravity Steam at 250°F/121°C for 30 minutes. .
KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.
KIMGUARD* ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.
The sheets of sterilization wrap are square or rectangular fabric produced using a threelayer SMS (spunbound-meltblown-spunbound) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of antistatic treatment. The wrap allows a sterilized package to be opened aseptically.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KIMGUARD ONE-STEP Sterilization Wrap:
Acceptance Criteria and Device Performance for KIMGUARD® ONE-STEP® Sterilization Wrap
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sterilization Efficacy (Gravity Steam) | Passed |
| Sterilant Penetration | Passed |
| Package Integrity/Physical Properties | Passed |
| Drying and Aeration | Passed |
| Maintenance of Package Integrity | Passed |
| Biocompatibility (pre- and post-sterilization) | Passed |
| Maintenance of Package Sterility (Duration) | 30 days |
Note: The document states that "All results of testing met the same acceptance criteria as the predicate devices demonstrating substantial equivalence to the predicate devices." While specific, numerical acceptance criteria are not explicitly detailed (e.g., minimum tensile strength), the "Passed" designation for each category indicates successful fulfillment of the established criteria, which are identical to those of the predicate devices (K082177 and K091685). The specific loads and weights for each wrap model also represent acceptance criteria for their respective uses.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample size used for the test sets (e.g., how many wraps were tested for sterilant penetration). However, it lists the types of loads used in the "Sterility Maintenance Validation Study" for each wrap model:
- KC100: 1 tray liner 20" x 25", 12.5" x 9" x 1" Tray, 1 lb of metal mass
- KC200: 1 tray liner 20" x 25", 10" x 20" x 3 ½ Tray, 3 lbs of metal mass
- KC300: 1 tray liner 20" x 25", 10" x 20" x 3 ½Tray, 6 lbs of metal mass
- KC400: 1 tray liner 20" x 25", 10" x 20" x 3 ½ Tray, 10 lbs of metal mass
- KC500: 1 tray liner 20" x 25", 11" x 22" x 3 ½Tray, 12 lbs of metal mass
- KC600: 1 tray liner 20" x 25", 11" x 22" x 3 ½Tray, 20 lbs of metal mass
The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. It is implied to be prospective testing conducted for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests described are nonclinical, laboratory-based performance tests rather than studies requiring human expert interpretation for ground truth establishment.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as the tests are nonclinical performance evaluations rather than interpretive studies requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted. This type of study is typically for evaluating diagnostic or interpretive AI systems, not packaging materials.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical sterilization wrap, not an algorithm or AI system. The performance evaluation is inherently "standalone" in the sense that it assesses the physical product's characteristics and functionality.
7. The Type of Ground Truth Used
The ground truth for the nonclinical tests appears to be established scientific and regulatory standards/methods for sterilization packaging performance. This would include methods for assessing sterilant penetration, package integrity (e.g., burst strength, seal integrity), drying, aeration, and maintenance of sterility (e.g., microbial barrier testing). The "results of testing met the same acceptance criteria as the predicate devices," implying a comparison against established performance benchmarks for similar products.
8. The Sample Size for the Training Set
This is not applicable. The KIMGUARD ONE-STEP Sterilization Wrap is a physical medical device, not an AI or Machine Learning algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
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